Zou Anterior Lumbar Plate System
FDA 510(k)Class II (US FDA 510(k))
by Corelink Llc
Identifiers
- 510(k) Number
- K121791 FDA 510(k)
- FDA Product Code
- KWQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3060 FDA 510(k)
- Regulation Number
- 888.3060 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ZOU ANTERIOR LUMBAR PLATE SYSTEM is an orthopedic device intended for spinal fixation in the lumbar region. It is designed to provide stabilization and support following surgical procedures involving the anterior approach to the lumbar spine.
The device is supplied non-sterile and is intended for single-use. It is manufactured by Corelink, LLC and received FDA 510(k) clearance (K121791) on November 19, 2012, as substantially equivalent to a predicate device. The system includes plates and associated components for anterior lumbar plating applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121791 | Class II | Active |
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Manufacturer
- Manufacturer
- Corelink Llc
- FDA Applicant
- Corelink, LLC
Sources (1)
- FDA 510(k) K121791 24 fields · synced Sep 23, 2026